The Effect of Different Volumes of Physical Exercise on the Immune System

NCT02331446 | Completed Results DMC

• 1 other identifier: 27371214.4.0000.5313
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will do an intervention on four groups of previously sedentary post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol; group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical protocol; group 4 - sedentary control women. The protocol consists of three sessions per week of concurrent training (half session with aerobic training and the other part with weight training). Inflammatory and oxidative parameters will be analyzed and the investigators hypothesized that 90 minutes per week of concurrent training (group 1) will reduce the inflammatory parameters and the oxidative stress, and this improvements will be greater so much as the longer the sessions (a dose-response effect). The physical activity practiced out of the intervention will be controlled by a questionnaire (the commuting and leisure sections of the International Physical Activity Questionnaire) and the food intake by a 24-hour food recall.

Conditions

Immune System Diseases; Oxidative Stress

Outcome Measures

Primary Outcomes (7)

• Change in Interleukin-6

  Weeks 0, 6 and 12

• Change in Adenosine Deaminase Activity

  Weeks 0, 6 and 12

• Change in Butyrylcholinesterase Activity

  Weeks 0, 6 and 12

• Change in Thiobarbituric Acid Reactive Substances

  Weeks 0, 6 and 12

• Change in Total Thiol Content

  Weeks 0, 6 and 12

• Change in Glutathione Peroxidase Activity

  Weeks 0, 6 and 12

• Change in Superoxide Dismutase Activity

  Weeks 0, 6 and 12

Secondary Outcomes (2)

• Change in Performance in the Six-minute Walk Test

  Weeks 0 and 12

• Change in Handgrip Strength

  Weeks 0 and 12

Other Outcomes (7)

• Change in Body Mass Index

  Weeks 0 and 12

• Change in Minutes Per Week of Physical Activity Out of Intervention

  Week 0 and 12

• Change in Calories Intake

  Weeks 0 and 12

Study Arms (4)

Control

NO INTERVENTION

The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.

90 minutes per week

EXPERIMENTAL

The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.

Behavioral: Physical exercise intervention

150 minutes per week

EXPERIMENTAL

The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.

Behavioral: Physical exercise intervention

210 minutes per week

EXPERIMENTAL

The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.

Behavioral: Physical exercise intervention

Interventions

Physical exercise intervention BEHAVIORAL

150 minutes per week; 210 minutes per week; 90 minutes per week

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women have to be in the postmenopausal period, without physical disorders.

You may not qualify if:

• Women who answer positively to, at least, one of the issues of the PAR-Q instrument;
• Women with diabetes and/or cancer history;
• Women who underwent oophorectomy.

Sponsors & Collaborators

• Federal University of Pelotas: lead

MeSH Terms

Conditions

Immune System Diseases

Limitations and Caveats

The test performed to estimate the cardiorespiratory fitness was not specific to measure physical activity performed by the women. The test was done walking (six-minute walking test) and the aerobic training was carried out on cycle-ergometers.

Results Point of Contact

• Title: Msc. Matheus Pintanel Freitas
• Organization: Federal Universisty of Pelotas

matheus.pintanel@hotmail.com

Study Officials

• Matheus P Freitas

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters course student

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 6, 2015
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 29, 2016
• Results First Posted: August 23, 2016

Record last verified: 2016-08